Patients with rare autoinflammatory diseases in the UK have a new treatment option with the launch of Sobi’s Kineret (anakinra) following approval from the European Medicines Agency (EMA) earlier this year.
The drug is already licensed in the UK for treating rheumatoid arthritis and cryopyrin-associated periodic syndromes (CAPS). It will now be available to patients with adult onset stills disease (AOSD) and systemic-onset juvenile idiopathic arthritis (SIJA), which impacts children under the age of 16 years.
AOSD affects one or two people in a million, with up to an estimated 110 cases a year in England. Around 100 children a year are diagnosed with SIJA, making up 10% of juvenile idiopathic arthritis (JIA) diagnoses.
These rare autoimmune diseases produce symptoms including high fevers, rashes, swollen lymph nodes, developing into joint and muscle pain.
Anakinra is a biologic immunosuppressive medicine that blocks the activity of the chemical messenger interleukin 1 (IL-1). It is the only IL-1 receptor antagonist that blocks this activity in both patient groups. The drug is administered daily via subcutaneous injection.
The EMA approval follows the evaluation of more than 400 patients with Still’s disease. The case study and clinical trial findings revealed positive results for patients treated with anakinra, including the possibility of remission.
NHS England recommended anakinra as a third line treatment in its Clinical Commissioning Policy for AOSD treatment.
Dr Sinisa Savic, a consultant in clinical immunology and allergy at St James’ University Hospital in Leeds, said: “This is an important step in providing additional therapeutic options for the UK Still’s patients, especially for those who have not responded to previous treatments.
“Furthermore, the new NHS England policy for patients with AOSD is a positive step, providing clinicians with additional options to treat patients who do not respond to corticosteroids and [disease modifying anti-rheumatic drugs] DMARDs.”
Dr Savic added: “No therapy is consistently effective in all cases, so having additional treatments that can be given in a combination with other disease-modifying antirheumatic drugs or as a monotherapy will help to address this unmet need.”
Anakinra will now be offered to patients over eight months with moderate to high disease activity, and those with continued activity after receiving treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
Neil Dugdale, general manager UK and RoI at Sobi, said: “We are very pleased that Kineret is now licenced for patients with SIJA and AOSD, particularly because it has been granted this new indication, partly as a result of clinicians publishing their case reports over many years, as well as running small trials, showing very positive results, including that remission is possible.”
